- Organized by DahShu IDSWG Oncology Team
- Date: Friday, May 2, 2025
- Time: 1:00pm – 5:00pm EDT (Hybrid)
- Pre-Meeting networking: 11:00am – 12:00pm (In-Person attendees only)
- Lunch included: 12:00pm – 1:00pm (In-Person attendees only)
- Attendees in Boston area come in person and enjoy the pre-meeting networking at 11:00am. Due to the limited seats in the conference room, please inform us in advance if you plan to come in person. Most participants attend virtually.
- Participation by invitation only
Objective
Since Project Optimus, there has been significant advances in trial design and practice. The purpose of the KOL roundtable and panel discussion is to develop a whitepaper for a systemic review of the recent advances and practical considerations in clinical studies for dose optimization.
Invited Speakers and Panelists
- Prof. Ying Yuan, Ph.D., Statistics, The University of Texas, MD Anderson Cancer Center
- Prof. Shing Lee, Ph.D., Statistics, Columbia University Irving Medical Center
- Prof. Yong Zang, Ph.D., Statistics, Indiana University School of Medicine
- Dr. Milind Javle, M.D., Physician, Department of Gastrointestinal Medical Oncology. The University of Texas, MD Anderson Cancer Center
- Dr. Christopher T Chen, M.D., Physician, Stanford Medicine
- Bo Huang, Ph.D., Statistics, Pfizer
- Jean Fan, M.D., Clinical, TransThera Biosciences
- Xuyang Song, Ph.D., MBA, Clinical Pharmacology, Adlai Nortye
- Eric Richards, PhD., Medicines Development, GSK
- Marc R. Gastonguay, Ph.D. Clinical Pharmacology & Pharmacometrics (Metrum Research Group)
- Shaily Arora, Regulatory Affairs, AstraZeneca
- Alysia Baldwin-Ferro, Regulatory Affairs, BeOne Medicines
Program Schedule
| Time | Topic / Session | Presenters |
| 11:00-12:00 | Welcome & Check In | Leonard Gold (NJS) |
| 12:00-13:00 | Lunch | In-Person Attendees (By Invitation Only) |
| Session 1. Moderator: Philip He | ||
| 13:00 – 13:10 | Introduction and Purpose | Philip He (Daiichi Sankyo) |
| 13:10 – 13:25 | Clinical Perspectives on Dose Optimization in Oncology | Jean Fan (TransThera) |
| 13:25 – 13:40 | Overview efficacy-integrated dose optimization strategy and two-stage dose optimization strategy | Ying Yuan (MD Anderson) |
| Session 2. Panel Discussion 1 Moderator: Gu Mi (Sanofi) | ||
| 13:40 – 14:25 | Panel Discussion 1: Clinical Development Strategy Q1: Timing Q2: Different indications Q3: Biomarker Q4: Disease Setting Q5: Drug Class | Physicians/Clinical: Christopher T Chen (Stanford), Milind Javle (MD Anderson), Jean Fan (TransThera) Clinical Pharm: Xuyang Song (Adlai Nortye), Marc R. Gastonguay (Metrum) Statistics: Ying Yuan (MD Anderson), Yong Zang(Indiana U), Bo Huang(Pfizer), Shing Lee (Columbia U) Regulatory: Shaily Arora (AstraZeneca), Alysia Baldwin-Ferro (BeOne Medicines) |
| 14:25 – 14:40 | Coffee Break | |
| Session 3. Moderator: Revathi Ananthakrishnan (BMS) | ||
| 14:40 – 14:55 | Clinical Pharmacology Perspectives in Oncology Dose Optimization | Marc Gastonguay (Metrum) |
| 14:55 – 15:10 | Seamless design strategies for dose optimization in oncology | Bo Huang (Pfizer) |
| Session 4. Moderator: Cindy Lu (AstraZeneca) | ||
| 15:10 – 15:55 | Panel Discussion 2 (45 min) Study Design Q6: Sample size Q7: Randomization Q8: Futility Analysis Q9: Endpoints | Physicians/Clinical: Christopher T Chen (Stanford), Milind Javle (MD Anderson), Jean Fan (TransThera) Clinical Pharm: Xuyang Song (Adlai Nortye), Marc R. Gastonguay (Metrum) Statistics: Ying Yuan (MD Anderson), Yong Zang(Indiana U), Bo Huang(Pfizer), Shing Lee (Columbia U) Regulatory: Shaily Arora (AstraZeneca), Alysia Baldwin-Ferro (BeOne Medicines) |
| 15:55 – 16:10 | Coffee Break | |
| Session 5. Moderator: Patrick Mitchell (AstraZeneca) | ||
| 16:10 – 16:25 | Dose Optimization in the Context of Multi-cycle Safety Data | Shing Lee (Columbia University) |
| 16:25 – 17:10 | Panel Discussion 3 (45 min) Combination Therapy and Regulatory Considerations Q10. Necessity of dose optimization for combination when monotherapy dose determined Q11. Necessity of dose optimization for monotherapy when monotherapy is not expected effective. Q12. Novel + Novel Q13. Regulatory experiences Q14. Regulation vs Innovation | Physicians/Clinical: Christopher T Chen (Stanford), Milind Javle (MD Anderson), Jean Fan (TransThera) Clinical Pharm: Xuyang Song (Adlai Nortye), Marc R. Gastonguay (Metrum) Statistics: Ying Yuan (MD Anderson), Yong Zang(Indiana U), Bo Huang(Pfizer), Shing Lee (Columbia U) Regulatory: Shaily Arora (AstraZeneca), Alysia Baldwin-Ferro (BeOne Medicines) |
| 17:10 – 17:20 | Next Steps | Philip He (Daiichi Sankyo) |
Program Committee
- Revathi Ananthakrishnan (Bristol Myers Squibb)
- Arunava Chakravartty (Novartis)
- Gina D’Angelo (AstraZeneca)
- Dong Xi (Gilead)
- Leonard Gold (NJStat)
- Philip He (Daiichi Sankyo)
- Nicole Li (BeOne Medicines)
- Cindy Lu (AstraZeneca)
- Haijun Ma (Exelixis)
- Gu Mi (Sanofi)
- Patrick Mitchell (AstraZeneca)
- Yujun Wu (Eli Lilly)
Location
- In-person participants:
307 Waverley Oaks Rd # 209, Waltham, MA 02452, USA
- Remote participants: meeting link will be provided prior to the event.
Sponsor
We will plan similar events in the future for various practical topics in oncology drug development. If you would like to contribute / involve in the future events, please contact us. We may consider to open the future events to the public when the IT capacity allows. If you would like to sponsor our events, please contact us.
Dahshu IDSWG Oncology 